Inhaled corticosteroids versus sodium cromoglycate in children and adults with asthma

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Abstract
Inhaled corticosteroids (ICS) and sodium cromoglycate (SCG) have become established as effective controller medications for children and adults with asthma, but their relative efficacy is not clear. To compare the relative effectiveness and adverse effects of ICS and SCG among children and adults with chronic asthma. Systematic search of the Cochrane Airways Group's special register of controlled trials (to Feb. 2004), hand searches of the reference lists of included trials and relevant review papers, and written requests for identification of additional trials from pharmaceutical manufacturers. Randomized controlled trials comparing the effect of ICS with SCG in children and adults with chronic asthma. All studies were assessed independently for eligibility by three review authors. Disagreements were settled by consensus. Trial authors were contacted to supply missing data or to verify methods. Eligible studies were abstracted and fixed‐ and random‐effects models were implemented to pool studies. Separate analyses were conducted for paediatric and adult studies. Subgroup analyses and meta‐regression models were fit to explore heterogeneity of lung function outcomes by type of RCT, category of ICS or SCG dosage, asthma severity of participants, and study quality on outcomes. Of 67 identified studies, 17 trials involving 1279 children and eight trials involving 321 adults with asthma were eligible. Thirteen (76%) of the paediatric studies and six (75%) of the adult studies were judged to be high quality. Among children, ICS were associated with a higher final mean forced expiratory volume in 1 second [FEV1] (weighted mean difference [WMD] 0.07 litres, 95% confidence interval [CI] 0.02 to 0.11) and higher mean final peak expiratory flow rate [PEF] (WMD 17.3 litres/minute, 95% CI 11.3 to 23.3) than SCG. In addition, ICS were associated with fewer exacerbations (WMD ‐1.18 exacerbations per year, 95% CI ‐2.15 to ‐ 0.21), lower asthma symptom scores, and less rescue bronchodilator use than SCG. There were no group differences in the proportion of children with adverse effects. Among adults, ICS were similarly associated with a higher mean final FEV1 (WMD 0.21 litres, 95% CI 0.13 to 0.28) and a higher final endpoint PEF (WMD 28.2 litres/minute, 95% CI 18.7 to 37.6) than SCG. ICS were also associated with fewer exacerbations (WMD ‐3.30 exacerbations per year, 95% CI ‐5.62 to ‐0.98), lower asthma symptom scores among cross‐over trials but not parallel trials, and less rescue bronchodilator use than SCG. There were no differences in the proportion of adults with adverse effects. In subgroup analyses involving lung function measures, paediatric and adult studies judged to be of high quality had results consistent with the overall results. Lung function measures in children were higher in studies with medium BDP‐equivalent steroid dosages than low BDP‐equivalent dosages, while adult studies could not be compared by steroid dosage since they all incorporated similar dosages. There were no significant differences in lung function by the asthma severity of participants for adult or child studies. ICS were superior to SCG on measures of lung function and asthma control for both adults and children with chronic asthma. There were few studies reporting on quality of life and health care utilization, which limited our ability to adequately evaluate the relative effects of these medications on a broader range of outcomes. Although there were no differences in adverse effects between ICS and SCG, most trials were short and may not have been of sufficient duration to identify long‐term effects. Our results support recent consensus statements in the U.S. and elsewhere that favour the use of ICS over SCG for control of persistent asthma. 吸入式皮質類固醇相較於色甘酸鈉治療兒童及成人氣喘患者 吸入式皮質類固醇(ICS)及色甘酸鈉(SCG)已被確認為兒童及成人氣喘患者有效的控制藥物，但其相對效益並不清楚。 比較ICS及SCG對兒童及成人慢性氣喘患者之相對效益及不良效應。 系統性搜尋Cochrane Airways Group special register of controlled trials(至2004年2月)、人工搜尋納入試驗及相關回顧性文章之參考文獻，以及寫信要求藥品製造商找出額外的試驗。 比較ICS及SCG對兒童及成人慢性氣喘患者之效益的隨機對照試驗。 所有研究均由三位審查者獨立地評估其是否合適。意見不合處以建立共識來處理。聯絡作者提供漏失的數據及確認研究方法。合資格的研究予以摘錄並使用固定及隨機模式整合研究。成人及兒科的研究則分別分析。依RCT的型式、ICS或SCG劑量分類、參與者氣喘的嚴重度、研究結果的品質導致肺功能結果的差異而作分組分析及綜合迴歸分析用來探討。 在67個被找到的研究中，17項涉及1279名兒童及八項涉及321名成人氣喘息者的研究適作分析。兒科研究中有13項(76%)及成人研究中有六項(75%)被判定為高品質。在兒童研究中，使用ICS的病人較使用SCG者有較高的一秒最終平均用力呼氣容積(FEV1)(加權均數差﹝WMD﹞0.07 L，95%信賴區間﹝CI﹞0.02至0.11)及較高的平均最終尖端呼氣流量(PEF)(WMD 17.3 L/min，95% CI 11.3至21.3)。此外，ICS較SCG伴隨較少的惡化(WMD −1.18次/年，95% CI −2.15至−2.01)、較低的氣喘症狀評分及較少使用救援性支氣管擴張劑。兒童不良效應的比例在各組別間無差異。在成人，ICS亦相似地較SCG有較高的平均最終FEV1(WMD 0.21 L，95% CI 0.13至0.28)及較高的最終終點PEF(WMD 28.2 L/min，95% CI 18.7至37.6)。ICS亦較SCG伴隨較少的惡化(WMD −3.30 次/年，95% CI...